The following data is part of a premarket notification filed by Trident S.r.l with the FDA for Rix70 Dc.
| Device ID | K182206 |
| 510k Number | K182206 |
| Device Name: | RiX70 DC |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | Trident S.r.l Via Artigiani 4 Castenedolo, IT 25014 |
| Contact | Giorgio Rizzo |
| Correspondent | Joyce St. Germain The 510k Consulting LLC 1449 Springleaf Dr. Ormond Beach, FL 32174 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-15 |
| Decision Date | 2018-09-13 |
| Summary: | summary |